BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC WIFI MX

    MDR report key: 25008064 · Received April 27, 2026

    Report

    Report Number
    3000240707-2026-00165
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 11, 2026
    Report Date
    April 27, 2026
    Manufacturer
    FRESENIUS VIAL S.A.S
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: WHILE CHECKING THE 24-HOUR INFUSIONS, IT WAS NOTED THAT THE DOXORUBICIN INFUSION HAD 10 ML REMAINING AND WAS NEARING COMPLETION: AT APPROXIMATELY 8:20 A.M., AT WHICH TIME IT FINISHED. THE INFUSION WAS SCHEDULED TO END AT 10:40 A.M.; THE PHARMACIST ON DUTY WAS NOTIFIED. THE SHIFT LOG INDICATED THAT A FRESENIUS PUMP HAD BEEN REPLACED THE PREVIOUS NIGHT BECAUSE THE INFUSION HAD RUN DRY ON SEVERAL OCCASIONS. MEDICAL HISTORY: ON (B)(6) 2026 AT 8:00 AM, I VISITED THE PATIENT IN WARD 116. THE PATIENT WAS CONSCIOUS, ALERT, ORIENTED, AND AFEBRILE. DA-EPOCH PROTOCOL: CYCLE 5, DAY 2. AFTER PRIOR SKIN ASEPSIS AND ANTISEPSIS USING STERILE TECHNIQUE, AN IMPLANTABLE CATHETER WAS INSERTED INTO THE RIGHT HEMITHORAX USING A 20G X 0.75 SURECAN NEEDLE; VENOUS RETURN WAS OBTAINED AND SALINE SOLUTION FLOWED WITHOUT DIFFICULTY; A 3-WAY STOPCOCK WAS PLACED; THE SITE WAS COVERED WITH A TEGADERM 8. 5X10, AND THE EQUIPMENT IS CONNECTED FOR THE XL PHOTOSENSITIVE INFUSION PUMP AND, VIA CHANNEL B, THE MACRO-DRIP SET, AS WELL AS THE FRESENIUS PHOTOSENSITIVE INFUSION PUMP. PREMEDICATION IS INITIATED WITH: ONDANSETRON 16 MG IN 100 ML OF 0.9% SALINE SOLUTION - PREDNISONE 100 MG PO. (B)(6) 2026 11:11 10+40 A PUSH-STOP TECHNIQUE IS PERFORMED ON THE PERMEABLE IMPLANTABLE CATHETER; VENOUS RETURN IS CONFIRMED. 24-HOUR INFUSIONS ARE INITIATED AS FOLLOWS: 1. DOXORUBICIN 18.1 MG IN 500 ML OF 0.9% SALINE AT 20.8 ML/H VIA A PHOTOSENSITIVE FRESENIUS PUMP. SIMILARLY, VINCRISTINE 0.72 MG IS ADMINISTERED IN 500 ML OF 0. 9% AT A RATE OF 20.8 CC/H VIA A PHOTOSENSITIVE XL PUMP; FINALLY, VIA A MACRO-DRIP PUMP IN A CONCOMITANT Y-LINE INFUSION, ETOPOSIDE 90 MG IN 400 CC OF 0.9% SALINE AT 16.7 CC/H. PATIENT TOLERATING TREATMENT; THE DEPARTMENT IS NOTIFIED. (B)(6) 2026: 8:00 AM I VISIT THE PATIENT IN UNIT 116; THE PATIENT IS CONSCIOUS, ALERT, ORIENTED, AND AFEBRILE. THE PATIENT HAS NO FAMILY MEMBERS PRESENT; I INTRODUCE MYSELF AND EXPLAIN THE TREATMENT TO BE INITIATED. DA-EPOCH PROTOCOL, CYCLE 5, DAY 3. PREDNISONE 100 MG PO IS ADMINISTERED. UPON CHECKING THE 24-HOUR INFUSIONS, IT WAS NOTED THAT THE DOXORUBICIN MEDICATION HAD A REMAINING VOLUME OF 10 ML AND WAS NEARLY FINISHED: APPROXIMATELY AT 8:20 A.M., AT WHICH TIME IT CONCLUDED. THE INFUSION WAS SCHEDULED TO END AT 10:40 A.M. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EVENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356545 AGILIA VP MC WIFI MX INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S Z019732

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown